Federal health officials released two proposed rule changes for CMS and ONC this February that make clear the agencies intentions to move interoperability in healthcare and patient access to data forward. The large scope of these rules should make an overall impact on the EHR landscape. We’ve provided a quick overview below.

Focused on improving interoperability and patient-provider communications, the two rules are separate, but reinforce the same core concept – interoperability and patient access must move forward faster. The rules put healthcare IT stakeholders under greater scrutiny to keep health data moving smoothly without restrictions.

21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT

The ONC’s extensive new rule is designed to provide patients and providers with secure access to new tools and healthcare data. The rule promotes the adoption of standardized APIs to facilitate secure access to data through mobile applications. One provision would require providing free digital access to electronic health data for patients.

Significantly, enforcement of the information blocking provisions from the 2016 Cures Act will begin. The act specified information blocking as the practice of preventing, interfering with or materially discouraging access, exchange or use of electronic healthcare data. Developers, health information exchanges and health information networks will be subject to up to $1 million in fines per violation if they are found at fault. Providers are not subject to any monetary penalty.

Reasonable exceptions to the information blocking definition practices are also detailed. These include preventing any harm, promoting EHR privacy and security, and recovering reasonable data access costs. Additionally, responding to infeasible requests, licensing of interoperability elements or reasonable, non-discriminatory terms and improving and maintaining performance would also be excluded from information blocking penalties.

Requiring health IT developers to publish their APIs, allowing healthcare information to be accessed, used and exchanged without special effort, is also recommended. Of special note, the ONC is calling for the use of the FHIR standard for APIs, and developers must provide access to all of the available data elements of the patient’s EHR, as permitted under current privacy laws.

Finally, developers must also test the real-world efficacy of their technology in the type of setting in which it’s intended to be marketed, and provide attestation to the Conditions of Certification every six months as specified in the Cures Act, with the exception of the EHR reporting criteria submission.

Interoperability and Patient Access Proposed Rule

CMS lists similar conditions within their proposed rule, such as requiring FHIR for APIs, but with a greater focus on its associated healthcare plans. It’s recommending a requirement that Medicare Advantage, Medicaid programs, CHIP programs, and QHP issuers in the federal facilitated exchanges implement, test, and monitor openly-published, FHIR-based APIs, in order to make patient health information available through third party applications. It also proposes compelling these programs to support the electronic exchange of data through transition of care, allowing data to transfer as the patient moves between plan types.

Furthermore, CMS is proposing that payers in their programs participate in a trusted exchange network. Such a network would allow payers to join any health information network they choose, and still participate in nationwide data exchange. This move is part of a larger push that by 2020, Medicare, Medicaid and plans in the federal health insurance exchanges will allow all patients to obtain their data through APIs.

Notably, CMS is also proposing to make electronic notifications of patient admission, transfer or discharge a condition of participation in Medicare for hospitals. It also intends to make public the names of clinicians and hospitals submitting “no” to three attestation statements committing to data sharing, to help prevent information blocking practices.

The specific impact that these changes will make on the healthcare industry remains to be seen. Both rules are currently open to public comment. One concept is clear; the push towards interoperability and greater patient access is here.